MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-541PA; TRANSMITTER

Model Number	ZM-541PA
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Issue (2379); Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the transmitter is giving off inaccurate ecg readings.The customer changed the batteries, leads, and put it on a simulator.The device was returned to nihon kohden for evaluation.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.
Event or Problem Description
The customer reported that the transmitter is giving off inaccurate ecg readings.
Additional Manufacturer Narrative
Complaint details: customer reported that their zm-541pa's ecg was giving incorrect readings.The transmitter was tested with different cables and a simulator, but the issue persisted.Service requested: exchange.Service performed: exchange the customer was sent an exchange unit to resolve the issue.The customer's defective unit was received.Defective unit cannot perform operation channel change.The unit was cleaned and evaluated.It had fluid intrusion and was contaminated.Scrap unit.Investigation result: the root cause of the issue was found to be customer mishandling the unit/customer abuse.Evidence of mishandling can be seen through the device having fluid intrusion.Fluid intrusion affects the device's internal components and can affect the overall function of the unit.Based on the given information, this issue is not suspected to be caused by deficient device or design.Corrected information: device available for evaluation? (date returned).
Event or Problem Description
The customer reported that the transmitter is giving off inaccurate ecg readings.

• Brand Name: ZM-541PA
• Common Device Name: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 7646156
• Report Number: 8030229-2018-00239
• Device Sequence Number: 13862559
• Product Code: DRT
• UDI-Device Identifier: 04931921106617
• UDI-Public: 04931921106617
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K043517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019
• Report Date (Section F): 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ZM-541PA
• Device Catalogue Number: ZM-541PA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/01/2019
• Device Age: 34 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2019
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NOT APPLICABLE
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/02/2019